Heartburn Drugs Prilosec and Nexium May Cause Heart Attacks

By consumeristcareyAugust 11, 2007

The FDA has launched a safety review of the heartburn drugs Prilosec and Nexium after two studies linked the medicines to an increased risk of: “heart attacks, heart failure, and heart-related sudden death.” The FDA warned that the studies are only preliminary, and that doctors and patients should keep using the drugs. From the LA Times:

Nexium and Prilosec are part of a family of drugs that reduce production of stomach acid. Intended to relieve chronic heartburn and acid reflux disease, which can damage the esophagus, they are also widely taken for routine stomach upset.

The two drugs have been taken by more than 1 billion patients worldwide. Many doctors believe such medications are overused, according to Consumer Reports.

Nexium was the sixth-most commonly prescribed brand-name drug last year, according to Drug Topics, an Internet magazine.

AstraZeneca, the maker of both drugs, defiantly stated: “The products are not associated with an increased risk of cardiac events.” Ok, Mr. Profitable Drug Maker, thanks for clearing that up. The FDA safety review should provide more answers within three months.

Except that the Washington Post reported that the investigation into these studies started back in May and the FDA’s announcement on Thursday was to state that there didn’t seem to be a causal link between taking the medication and having increased heart trouble. As near as I can tell by reading it, the study was flawed and created a false relationship because the group not taking the medication skewed towards younger people with fewer heart problem.

Precisely. I remember a big deal being made about these studies about three months ago amongst pharmacists and people involved in retail pharmacy, but it all ended up sputtering out when the FDA said the study was more or less a bunch of crap.

As per it being scaremongering… more than likely. At the very least, it’s effective. Without fail, every time a pharmacy-related topic appears on Oprah/Today Show/Dateline/*insert widely watched news show*, a deluge of patients come in with inane questions, concerns, or requests. And 90% of the time, they don’t actually understand whatever it is they’re referencing or talking about.

“Can I get a generic for my *insert brand only drug here*? I hear it’s just as good!”
“Can I get the brand name version of *insert cheap generic drug whose brand equivalent is insanely expensive*? I hear that generics aren’t as good!”
“Where do you keep Netti Pots?”
“Can I stop taking Avandia?”

“”At this time, FDA’s preliminary conclusion is that collectively these data do not suggest an increased risk of heart problems,” said an agency statement.”

“In the study involving Prilosec, 17 patients taking the medication had serious heart problems, compared with eight in the group that had surgery, AstraZeneca said. However, the Prilosec patients appeared to have been in poorer health to begin with. Six of the Prilosec patients had had previous heart attacks, compared with none in the group that had surgery.
“

Heartburn drugs are one of the fastest growing segments of the pharma industry due to the fact that heartburn is one of the top side effects of Lipitor & other statins. There is a ton of money tied into these products, and I doubt they will be pulled off the shelf any time soon.

Also, to go along with what Lruettmann was saying… It’s not just statins. Heartburn and upset stomach are side effects of basically every single drug known to man. Coupled with the fact that it seems that everyone and their mother over the age of 50 is prescribed Nexium and aspirin by their doctors, I doubt we’ll see a drop in PPI usage anytime soon.

Also, if you look at the studies, where they compared patients head to head, the patient population taking the PPI’s actually had a LOWER rate of cardiac events. There was only one study which showed a higher rate of cardiac events, and that was not the same patient population in both study groups.

So unless the FDA comes up with new studies, this is just a case of CYA by the FDA after getting embarrased by the COX-2 and glitazone scandals.